Job Description

Responsibilities:

Strategic Leadership & Planning

(a) Develop and execute the APAC regulatory and quality affairs strategy aligned with business


objectives and market expansion goals.


(b) Define and drive the regulatory pathway strategy for product portfolios to optimize time-tomarket


and competitive positioning.


(c) Support data privacy and information security initiatives in partnership with the Information


Security teams to fulfill national data privacy and Information Security regulatory requirements.

Quality Management System Oversight

(a) Provide oversight of the Quality Management System (ISO 13485) to ensure effectiveness,


compliance, and continuous improvement.


(b) Lead preparation and responses for regulatory inspections, audits by Notified Bodies, and


certification body assessments.


(c) Oversee post-market surveillance programs and ensure timely escalation and resolution of


regulatory issues.


(d) Partner with cross-functional teams to integrate regulatory and quality considerations into


product development, business planning, and commercial strategies.

Regulatory Submissions & Approvals

(a) Lead and directly manage critical regulatory submissions for pre-market product registrations,


license renewals, and major amendments across US and APAC markets.


(b) Oversee the preparation and quality of technical documentation, dossiers, and regulatory


filings to ensure accuracy and compliance.


(c) Develop and maintain relationships with regulatory authorities to facilitate efficient review


processes and address regulatory questions.

Team Leadership & Development

(a) Build, lead, and mentor a high-performing regulatory and quality affairs team.


(b) Develop organizational capabilities and foster a culture of quality, compliance, and continuous


improvement.

Qualifications and Competency

(a) At least Bachelor's degree in Life Sciences, Biomedical Engineering or a related field.


(b) At least 5 years of professional experience in regulatory affairs and quality affairs in medical


device industry.


(c) In-depth knowledge of global regulatory frameworks (US FDA, EU MDR, TGA, SG HSA etc)


(d) Strong knowledge and understanding of ISO 13485, manufacturing and quality standards


(e) Excellent project management, organizational and problem solving skills


(f) Strong attention to details with the ability to manage multiple priorities and deadlines.


(g) Excellent written and verbal communication skills


(h) Background in software development or medical device manufacturing would be an added


advantage.